China NMPA Product Recall - Acetabular cup system (trade name: Duraloc)

The National Medical Products Administration (NMPA) issued a recall notice on September 2, 2013, regarding an Acetabular Cup System manufactured by DePuy Orthopaedics, Inc. This voluntary recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on August 8, 2013, addresses a critical packaging error: the length of screws contained within the product packaging did not match the length specified on the labeling. This issue pertains to specific models (117215000 and 117230000) of cancellous bone screws used in total joint replacement surgeries. Although the company stated this particular recall does not affect mainland China, the NMPA's regulatory framework necessitates that all provincial, autonomous region, and municipal food and drug administrations strengthen their supervision of similar imported medical devices. DePuy Orthopaedics, Inc. is required to submit an investigation and evaluation report, an implementation plan, and a summary report to the State Food and Drug Administration. The company has indicated that no further corrective actions will be undertaken beyond these reporting obligations. Affected regions span Taiwan, Thailand, Slovenia, South Korea, United Kingdom, India, Israel, and Russia.